Slittable and peelable sheaths and methods for making and using them

ABSTRACT

A sheath for delivering a lead or other device into a body lumen is adapted to be removed from around the delivered lead or device via a longitudinally extending feature. This feature of the sheath may be a ripcord, a seam or interlocking features the releasably engage one another.

The present application is a continuation of U.S. application Ser. No.12/617,163 filed Nov. 12, 2009, now U.S. Pat. No. 7,837,671 now allowed,which is a divisional of U.S. application Ser. No. 11/563,142, filedNov. 24, 2006, now U.S. Pat. No. 7,637,902, which claims benefit of U.S.provisional application Ser. No. 60/739,249, filed Nov. 23, 2005, theentire disclosure of which is expressly incorporated by referenceherein.

FIELD OF THE INVENTION

The present invention relates generally to apparatus and methods fordelivering instruments and/or agents during a medical procedure, and,more particularly, to guide sheaths for accessing body lumens and/ordelivering instruments into body lumens of a patient and to methods formaking and using them.

BACKGROUND

Minimally invasive procedures have been implemented in a variety ofmedical settings, e.g., for vascular interventions, such as angioplasty,stenting, embolic protection, electrical heart stimulation, heartmapping and visualization, delivery of pacemakers, and the like. Theseprocedures generally rely on accurately navigating and placinginstruments within a patient's vasculature.

During such procedures, a target vessel may be accessed using a guidewire advanced through the intervening vasculature into the targetvessel, thereby providing a “railway” to the vessel. One or moreinstruments, e.g., catheters, sheaths, and the like, may be advancedover the guide wire or “rail” into a vessel, heart, artery, vein, and/orother body cavity or lumen.

In some cases, a sheath placed within a body cavity or lumen may then beused to deliver another device, such as a pacemaker lead, stentcatheter, another sheath, and/or other device. Further, it may bedesirable that such a delivery sheath exhibit certain properties, suchas pushability, kink resistance, retention of shape, and/or durabilityin order to facilitate its own navigation into a body lumen or cavityand subsequent placement of a lead or device through it. Yet further, itmay be desirable to maintain the stability of placement of a lead ordevice positioned within a body cavity or lumen while removing adelivery sheath. Removal is often accomplished by peeling, cutting, orslitting.

However, techniques (such as braid reinforcement) used to impartcharacteristics of pushability, kink resistance, and the like, maydecrease the ease with which a sheath may be removed. For example, abraid reinforced sheath must generally be cut away using a slitter orother cutting tool, rather than peeled away as a non braid reinforcedsheath might be. Further, cutting through a braid may be difficult orinconsistent, increasing the likelihood of dislodgment of a lead orother device during removal of the delivery sheath.

Accordingly, it may be useful to provide a delivery sheath that ispushable, kink resistant, and the like and/or that may be easily removedfrom a body while leaving a remaining lead or other device in placewithout substantially disturbing its placement.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate exemplary embodiments of the invention, inwhich:

FIG. 1A is a perspective view of an exemplary embodiment of a tubulardevice, including a lumen extending between proximal and distal endsthereof.

FIG. 1B is a cross-sectional view of the tubular device of FIG. 1A,taken along line 1B-1B, showing a reinforcing layer between an outerlayer and a liner surrounding a lumen.

FIG. 1C is a cross-sectional view of the tubular device of FIGS. 1A and1B, taken along line 1C-1C of FIG. 1B.

FIGS. 2A-2D are cross-sectional views showing a first method for makinga circumferentially interrupted reinforcing layer.

FIGS. 2E and 2F are cross-sectional views of tubular devices includingthe reinforcing layer of FIG. 2C.

FIGS. 3A and 3B are cross sectional views showing another method formaking a circumferentially interrupted reinforcing layer.

FIG. 3C is a cross-sectional view of a tubular device including thereinforcing layer of FIG. 3C.

FIG. 3D is a cross-sectional view of a circumferentially interruptedreinforcing layer including two circumferential interruptions.

FIG. 3E is a cross-sectional view of a tubular device including thereinforcing layer of FIG. 3D.

FIG. 4 is a cross-sectional view of a tubular device including acircumferentially interrupted reinforcing layer including tworeinforcing structures similar to those shown in FIGS. 2A-2D.

FIG. 5 is a cross-sectional view of a tubular device including acircumferentially interrupted reinforcing layer that defines lumens.

FIG. 6A is a cross-sectional view of another embodiment of a tubulardevice including a ripcord channel embedded with cords.

FIG. 6B is a cross-sectional view of a distal end of the tubular deviceof FIG. 6A.

FIGS. 7A and 7B are cross-sectional views of alternative embodiments oftubular devices that include different materials co-extruded together tofacilitate peeling the tubular devices apart.

FIGS. 8A and 8B are cross-sectional views showing a method for makinganother embodiment of a tubular device formed from a sheet includingends that interlock when the sheet is rolled into a tubular shape.

FIGS. 9A and 9B are cross-sectional views showing another method formaking another embodiment of a tubular device formed from a sheetincluding ends that interlock when the sheet is rolled into a tubularshape.

DETAILED DESCRIPTION

Turning to the drawings, FIGS. 1A-1C show an apparatus 10 for accessinga body lumen (not shown) and/or for delivering one or more fluids,agents, and/or instruments (also not shown) within a body lumen. Inexemplary embodiments, the apparatus 10 may be a delivery sheath, aguide catheter, a procedure catheter, an imaging device, or othertubular device that may be peeled apart or otherwise separated duringuse. The apparatus 10 may be sized for introduction into a body lumen,such as a vessel within a patient's vasculature, a passage within apatient's gastrointestinal tract, urogenital tract, reproductive tract,respiratory tract, lymphatic system, and the like.

Generally, the apparatus 10 is an elongate tubular member or deviceincluding a proximal end 12, a distal end 14 sized for insertion into abody lumen, and a lumen 16 extending between the proximal and distalends 12, 14. Optionally, the apparatus 10 may include one or moreadditional lumens (not shown), which may be disposed concentricallyaround or side-by-side with the lumen 16. The lumen 16 may be sized forreceiving a guide wire, procedure catheter, cardiac lead, needle, orother instrument (not shown), and/or for delivering fluids or otherflowable agents or materials therethrough.

Optionally, the distal end 14 may include a tapered, rounded, orotherwise shaped distal tip 15, e.g., to provide a substantiallyatraumatic tip and/or facilitate advancement or navigation throughvarious anatomy. In addition or alternatively, the distal end 14 mayinclude one or more therapeutic and/or diagnostic elements, e.g., one ormore balloons, stents, sensors, electrodes, steering mechanisms, imagingdevices, needles, and the like (not shown), depending upon theparticular intended application for the apparatus 10.

Optionally, the proximal end 12 may include a handle 13 and/or one ormore ports, e.g., port 17 communicating with the lumen 16. In additionor alternatively, the handle 13 and/or proximal end 12 may include oneor more connectors, such as luer lock connectors, electrical connectors,and the like, for connecting other devices (not shown) to the apparatus10, such as syringes, displays, controllers, and the like (also notshown). In addition, the handle 13 may include one or more actuators,such as sliders, buttons, switches, and the like, e.g., for activatingand/or manipulating components (also not shown) on the distal end 14 orotherwise operating the apparatus 10.

Optionally, the apparatus 10 may include one or more backbones orsupport members (not shown) that may extend at least partially betweenthe proximal and distal ends 12, 14, e.g., as disclosed in co-pendingapplication Ser. No. 10/423,321, filed Apr. 24, 2003, and Ser. No.11/347,361, filed Feb. 3, 2006, the entire disclosures of which areexpressly incorporated by reference herein.

With particular reference to FIGS. 1B and 1C, the apparatus 10 generallyincludes a reinforcing layer 18 and an outer layer 20 surrounding thelumen 16. Generally, the reinforcing layer 18 includes one or morecircumferential interruptions 19 (one shown in FIG. 1C) that mayfacilitate peeling or otherwise separating the apparatus 10, e.g., fromaround another device received within the lumen 16, as described furtherbelow.

Optionally, the apparatus 10 may include an inner layer 22, e.g.,including a relatively thin film, sheet, or other material including aninner surface 21. The inner liner may be formed of a variety ofmaterials to impart structural characteristics or for materialproperties. For example, a fluoro-polymer liner may be added to impartlubricity. Alternatively, a coated liner may be added for properties oflubricity, anti-thrombogenicity, hydrophilic characteristic, and thelike, as disclosed in co-pending application Ser. No. 11/340,904, filedJan. 26, 2006, the entire disclosure of which is expressly incorporatedby reference herein. The layers of the apparatus 10 may be attached toone another, e.g., by laminating, adhering, adhesive bonding, ultrasonicwelding, reflowing or other heating, and the like, as describedelsewhere herein.

The construction of the apparatus 10 may be substantially uniform or mayvary between the proximal and distal ends 12, 14 e.g., by varying theconstruction of the reinforcing layer 18, outer layer 20, and/or innerlayer 22 along the length of the apparatus 10. In addition, thereinforcing layer 18 and/or the material of the outer layer 20 may allowthe apparatus 10 to be twisted from the proximal end 12, e.g., to rotatethe distal end 14 within a patient's body. Optionally, the outer layer20, reinforcing layer 18, and/or inner layer 22 may include one or moresublayers (not shown), which may vary in construction in variousportions of the apparatus 10.

In one exemplary embodiment, the proximal end 12 may be substantiallyrigid or semi-rigid, e.g., providing sufficient column strength to allowthe apparatus 10 to be pushed from the proximal end 12, while the distalend 14 may be substantially flexible or semi-rigid. Thus, the distal end14 of the apparatus 10 may be advanced or otherwise manipulated within apatient's body from the proximal end 12 without substantial risk ofbuckling and/or kinking. Optionally, the outer layer 20 at or adjacentthe distal end 14 may be substantially flexible or semi-rigid and/or thereinforcing layer 18 may be terminated, e.g., to allow the distal end 14to bend easily or otherwise be advanced through tortuous anatomy and/orprovide a substantially atraumatic distal tip 15. For example, as shownin FIG. 1B, the reinforcing layer 22 may terminate within the distal end14 proximal to the distal tip 15, e.g., to provide a relatively soft,flexible, and/or atraumatic distal tip 15.

In exemplary embodiments, the reinforcing layer 18 may include one ormore round or flat wires, filaments, strands, braids, and the like. Thematerial of the reinforcing layer 17 may be formed from metal, such asstainless steel, plastic, woven fibers, such as glass, Kevlar, and thelike, or composite materials. Materials that may be used in the outerlayer 20 may include one or more of PEBAX, urethane, FEP, PFA,polyethylene (“PE”), polyamide (Nylon), silicone, polypropylene,polysulfone, polyvinylchloride (PVC), polystyrene, polycarbonate,polymethylmethacrylate, fluoro-polymer, polyester, nylon, and the like.The inner layer 22 may include polyurethane, e.g., having a thicknessbetween about 0.0001-0.01 inch (0.0025-0.25 mm), or other suitablepolymers such as polyolefin, PEBAX, nylon, silicone, polypropylene, andpolyethylene. Materials may be primarily selected for optimalmechanical, bonding, and/or other properties and subsequently impartedwith desired surface properties, for example lubricity, by coating.

In exemplary embodiments, the apparatus 10 may have an outer diameterbetween about half and twenty millimeters (0.5-20 mm) or between aboutone and five millimeters (1-5 mm), and a length between about five andone hundred fifty centimeters (5-150 cm). The inner layer 22 may have awall thickness between about 0.0001-0.01 inch (0.0025-0.25 mm) and theouter layer 20 may have a wall thickness between about 0.0005-0.2 inch(0.0127-5.08 mm).

FIGS. 2A-2E show a first embodiment of a tubular device 100 thatgenerally includes an outer layer 105 and an interrupted tubularreinforcing structure 103 including a circumferential interruption 106.The tubular device 100 may be at least a portion of a delivery sheath orother apparatus, such as the apparatus 10 shown in FIG. 1A. In thisembodiment, the circumferential interruption 106 is a longitudinalchannel that extends substantially axially, e.g., at least partiallybetween proximal and distal ends (not shown) of the tubular device 10.

An exemplary method for making the reinforcing structure 103 is shown inFIGS. 2A-2C. Initially, as shown in FIG. 2A, an elongate tubular braidor other tubular reinforcing structure 101 may be provided. The tubularstructure 101 may be a woven mesh, braid, or other material that mayprovide a desired reinforcement for the tubular device 100, e.g., formedfrom metal wire, such as stainless steel, Nitinol, and the like, havingflat, round, or other geometric configurations, from polymermonofilaments, such as nylon and the like, and/or from other thread-likematerials, such as twisted or woven synthetic or natural fibers.

Turning to FIG. 2B, the tubular braid 101 may be folded back onto itselfto define two longitudinal edges 102. As shown in FIG. 2C, the tubularbraid 101 may be folded or rolled, or the edges 102 may otherwise bebrought together to define the longitudinal channel 106 between theedges 102. Alternatively, as shown in FIG. 2D, the tubular braid 101 ofFIG. 2A may be flattened to define the longitudinal edges 106 afterwhich the edges 102 may be brought together to form the interruptedtubular reinforcing structure 103 having the longitudinal channel 106.These methods for forming the interrupted tubular reinforcing structure103 provide the advantage that they maintain the general integrity ofthe original tubular braid 101. Thus, the mechanical properties, e.g.,the pushability, kink resistance, shape retention, and/or durability ofthe resulting tubular device 100 may be more easily defined andmaintained. In addition, these methods avoid cutting fibers of the braid101, which may otherwise unravel as a result of cutting, which maychange the properties of the braid 101 and/or cause deterioration duringmanufacturing and/or use.

Turning to FIG. 2E, the interrupted tubular reinforcing structure 103may then be attached to a sheath body 105, e.g., to form compositetubular device 100, which may have enhanced properties compared to thesheath body 105 alone, e.g., enhanced pushability, kink resistance,retention of shape, and/or durability. The sheath body 105 may be formedsimilar to the outer layer 20 described above with reference to FIGS.1A-1C. The interrupted tubular reinforcing structure 103 may bemaintained within the sheath body 105 by friction fit, bonding withadhesive, reflowing to effectively incorporate the reinforcing structure103 into the sheath body 105 to form a composite construction, and/orother methods such as those identified elsewhere herein. In analternative embodiment, the interrupted tubular reinforcing structure103 may be incorporated over the sheath body 105 (not shown) rather thanwithin the sheath body 105 as shown.

The longitudinal channel 106 may have a relatively small width comparedto the circumference of the tubular device 100. Once the reinforcingstructure 103 is attached to the sheath body 105, the longitudinalchannel 106 may be filled with material, e.g., adhesive, material fromthe sheath body 105 that may flow into the longitudinal channel 106, andthe like. Alternatively, the ends 102 of the braid 101 may even abut oneanother yet provide a circumferential interruption 106, i.e., acircumferential discontinuity in the reinforcing structure 103 thatextends longitudinally along the tubular device 100.

The longitudinal channel or circumferential interruption 106 of theinterrupted tubular reinforcing structure 103 may facilitate removingthe tubular device 100, e.g., from around another device received withinthe tubular device 100, such as a pacing lead (not shown). For example,the tubular device 100 (or apparatus 10 of FIGS. 1A-1C incorporating thetubular device 100) may be introduced into a body lumen (not shown). Inone embodiment, the apparatus 10 may be introduced into a patient's bodyvia a percutaneous puncture and advanced through the patient'svasculature into the heart, e.g., through the right atrium, coronary,sinus, and into the coronary veins to access a target delivery site.Another device, e.g., a pacing lead (not shown), may be introducedthrough the lumen 16 of the apparatus 10 until the device is deliveredto the target delivery site. Once the device, e.g., lead, is properlypositioned, the apparatus 10, including the tubular device 100, may besplit along the circumferential interruption 106 to facilitate removingthe apparatus 10 from around the delivered device.

For example, a slitter or other cutting device (not shown) may cut alongthe circumferential interruption 106, i.e., passing between the ends 102of the braid 101, thereby only cutting through the sheath body 105 andnot the combined sheath body 105 and reinforcing structure 103. Withparticular reference to FIG. 1A, the slitter may be positioned at theproximal end 12 of the tubular device 10 and aligned with thecircumferential interruption 106 in FIG. 2E. The slitter may then beadvanced distally and/or the tubular device 10 may be pulled proximallyto cause the slitter to cut through the sheath body 105 along thecircumferential interruption 106, i.e., along the longitudinal channel106 and/or between the ends 102 of the reinforcing structure 103.

In an exemplary embodiment, a slitter may be incorporated into thehandle 13 and/or otherwise into the proximal end 12 of the apparatus 10such that the slitter is furnished to the user aligned with thecircumferential interruption 106. Otherwise, a guide element, e.g., agroove, slot, pocket, and the like, and/or a visual indicator (notshown) may be provided on the proximal end 12 of the apparatus 10 thatmay facilitate the user aligning a slitter with the circumferentialinterruption 106. Thus, when the slitter is aligned with the guideelement, the slitter is aligned with the circumferential interruption106. Exemplary handles and/or slitters that may be provided aredisclosed in co-pending application Ser. No. 10/958,034, filed Oct. 4,2004, the entire disclosure of which is expressly incorporated byreference herein.

Turning to FIG. 2F, an alternative embodiment of a tubular device 100′is shown that is constructed similar to the tubular device 100 shown inFIGS. 2A-2E. Unlike the previous embodiment, the tubular device 100′includes a circumferentially interrupted reinforcing layer 103′ thatincludes two circumferential interruptions 106.′ Initially, two tubularbraids 101′ may be provided that may be folded and rolled to definelongitudinal edges 102.′ The two folded and rolled braids 101′ are thenplaced within a sheath body 105 such that the longitudinal edges 102′ ofthe braids 101′ are disposed adjacent one another, thereby defining twolongitudinal channels 106.′ As shown, the tubular braids 101′ may havesimilar diameters such that they each define approximately half of theinterrupted reinforcing layer 103.′ Alternatively, the tubular braids101′ may have different diameters, e.g., if it is desired to place thecircumferential interruptions 106′ other than opposite one another. Itwill be appreciated that more than two circumferential interruptions106′ may be provided, if desired. In a further alternative, shown inFIG. 4, an inner layer 120 is shown within a tubular device 100″ thatincludes a circumferentially interrupted reinforcing layer 103″including a single circumferential interruption 106.″

Turning to FIGS. 3A-3C, another embodiment of a tubular device 200 isshown that generally includes a circumferentially interruptedreinforcing layer 203 and a sheath body 205, similar to the previousembodiments. Unlike the previous embodiments, the reinforcing layer 203includes a composite structure. As shown in FIG. 3A, a tubular braid201, which may be similar to those described above (or other reinforcingmaterial), may be attached to a tubular structure 204, which may beconstructed similar to the outer layer described above. As shown, thetubular braid 201 is placed inside the tubular structure 204 and the twolayers are incorporated to form a composite construction, e.g., usingmethods described elsewhere herein. Alternatively, the tubular braid 201may attached or placed around the tubular structure 204, rather thanwithin in.

Turning to FIG. 3B, the composite construction is then cut to create alongitudinal channel 206 defined by opposing longitudinal edges 202,thereby creating the circumferentially interrupted reinforcing layer203. Once cut, the longitudinal edges 202 may abut one another, yet befree to separate from one another. Alternatively, some of the compositeconstruction may be removed along the longitudinal channel 206 such thatthe longitudinal edges 202 remain spaced apart from one another by adesired distance. Turning to FIG. 3C, the reinforcing layer 203 may thenbe placed within a sheath body 205, which may be similar to the outerlayer described above. The reinforcing structure 203 and sheath body 205may be attached, e.g. using an adhesive, heat, and/or other methods forbonding or reflowing the materials.

Optionally, during this step, the width of the longitudinal channel 106may be controlled, e.g., using an elongate spacer (not shown). Forexample, an elongate rod or tube (not shown) may be inserted through theinterior of the reinforcing layer 203 that has a diameter slightlylarger than the lumen, thereby causing the longitudinal edges 202 toseparate a desired distance. The bonding, reflowing, or other processused to attach the sheath body 205 and the interrupted tubularreinforcing structure 203 may then be completed, whereupon the spacermay be removed.

Turning to FIGS. 3D and 3E, a sheath or tubular device 200′ may beprovided that includes multiple reinforcing structures and/or multiplelongitudinal channels or circumferential interruptions 206.′ Forexample, a composite construction including a tubular braid 201′ and atubular structure 204′ may be formed, similar to the embodiment shown inFIG. 3A. The composite construction may then be cut longitudinally atmultiple locations, e.g., at two circumferentially opposite locations,as shown in FIG. 3D, to provide two longitudinal channels 206.′ Thus,the circumferentially interrupted reinforcing layer 203′ may include tworeinforcing structures, each approximately semi-circular incross-section, leaving two longitudinal channels 206.′ The twostructures may then be attached to a sheath body 205′ similar to theprevious embodiments, as shown in FIG. 3E.

In this manner, a tubular device 200′ may be provided that may beremoved from around another device by peeling or separating the tubulardevice 200′ into two pieces, rather than slitting or cutting. Forexample, with additional reference to FIG. 1A, the handle 13 may includetwo handles, tabs, elongated ends, or other components attached to theproximal end 12 opposite one another over the two reinforcingstructures, which may facilitate a user gripping when pulling apart orpeeling away the tubular device 200.′ If the two components are pulledaway from one another (transversely relative to the longitudinal axis18), the tubular device 200′ may separate at the longitudinal channels206 initially at the proximal end 12 and propagating towards the distalend 14 of the apparatus 10, thereby separating the tubular device 200.Peeling apart may be facilitated by longitudinally scoring the tubularstructure 204′ and/or the sheath body 205,′ e.g., along the areaoverlying the longitudinal channels 206.′

Turning to FIG. 5, another embodiment of a reinforced tubular device 300is shown that is generally constructed similar to the embodiments shownin FIGS. 2A-2E. For example, the tubular device 300 generally includes acircumferentially interrupted reinforcing layer 303 and a sheath body305 attached to one another. The reinforcing layer 303 may be formedfrom a tubular braid 301 that is folded and rolled into itself to definelongitudinal edges 302 that define a circumferential interruption 306.Unlike the previous embodiments, the tubular device 300 includes one ormore lumens 307, e.g., formed at one or both of the longitudinal edges302 of the tubular braid 301.

For example, when (during or after) the tubular braid 301 is folded androlled, an elongate mandrel, e.g., a wire, tube, rod, and the like (notshown) may be placed within one or both of the loops defining thelongitudinal edges 302 of the tubular braid 301. With the mandrel(s)within the longitudinal edges 302, the reinforcing layer 303 may beformed and/or the reinforcing layer 303 may be attached to the sheathbody 305. Once the reinforcing layer 303 is attached to the sheath body305 to provide the tubular device 300, the mandrel(s) may be removed,thereby providing one or two lumens extending along the tubular device300 adjacent the main lumen. If multiple tubular braids are used toprovide the reinforcing layer 303, it may be possible to provide morethan two lumens, if desired. These lumens, formed in the wall of thetubular device 300, may be used for infusion of fluids, placement ofelectrical conducting wires, carrying pull wires, for example, in orderto construct a steerable sheath, and the like.

Turning to FIGS. 6A and 6B, yet another embodiment of a tubular device140 is shown that may be incorporated into an apparatus, such asapparatus 10 of FIGS. 1A-1C. Generally, the tubular device 140 may be asheath body that includes one or more ripcord channels 141, 142 in itsouter wall. One or more ripcords 143 may be placed within the ripcordchannels 141, 142, running longitudinally through the tubular device140. As shown, the ripcords 143 may run through respective peripherallumens 142 from a proximal end (not shown) of the tubular device 140(e.g., from proximal end 12 of apparatus 10 shown in FIG. 1A) to adistal end 144 of the tubular device 140, and then wrap around andreturn to the proximal end of the tubular device 140 through a centrallumen 141 (e.g., back to the proximal end 12).

After using the apparatus 10 to deliver a lead or other device (notshown) through main lumen 146, the ripcords 143 may be pulled (e.g.,from the proximal end 12 of the apparatus 10), causing the ripcords 143to tear through the wall 145 between the two lumens 141, 142 andcreating a longitudinal weakness or interruption in the tubular device140 along which the tubular device 140 may be peeled or torn away, e.g.,from a lead or other device (not shown) extending through the main lumen146, as described previously. The ripcords 143 may be formed from metalwire, such as stainless steel, Nitinol, and the like, having flat, roundor other geometric configurations, from polymer monofilaments, such asnylon and the like, or from other thread-like materials, such as twistedor woven synthetic or natural fibers. The sheath body 140 may beconstructed of the same materials enumerated with regard to the outerlayer and the other embodiments described above. Alternatively, theripcords 143 may themselves effectively comprise the wall of the tubulardevice 140 on either side of the central lumen 141 such that pulling theripcords effectively separates the tubular device 140 longitudinallyallowing the tubular device 140 to be removed from around a lead ordevice without requiring any further pealing or tearing of the tubulardevice 140. The ripcords 143 may be embedded within the wall of thetubular device 140, e.g., when the tubular device 140 is molded,extruded, or otherwise formed. Optionally, if additional longitudinaltears or weaknesses are desired, multiple ripcords (not shown) may beprovided along the length of the tubular device 140, e.g., at otherlocations around the circumference of the tubular device 140.Alternatively, if desired, only a single ripcord 143 may be provided(not shown).

Turning to FIGS. 7A and 7B, yet another embodiment of a peelable ortearable sheath body or tubular device 154 is shown. The sheath body 154may be co-extruded using two different materials 150, 151 (as shown inFIG. 7A) or 152, 153 (as shown in FIG. 7B). The materials may exhibitdecreased bonding strength or a differential in structural propertiessuch that a natural parting line is formed between them, thus enablingthe sheath body 154 to be more easily peeled or torn longitudinally.Alternatively, a single material may be utilized but modified withvarious additives to provided a similar decrease in bonding and/ordifferential in structural properties. For example, one part 151, 152 ofthe sheath body 154 may be constructed of an un-modified PEBAX. Theother part 150, 153 of the sheath body 154 may be constructed of amodified PEBAX having additives to decrease its ability to bond to theunmodified PEBAX. For example, a fluoro-polymer oil may be added.

Alternatively or in addition, modification of structural properties maybe accomplished by adding clay or glass in order to increases tensilestrength and decrease elongation of the modified material (for example,urethane or PEBAX) such that, when extruded next to an un-modifiedmaterial (for example urethane or PEBAX), the differential propertiesmay cause a natural part line during peeling away, thus facilitatingeasier removal of the sheath body 154 from around a lead or other device(not shown) delivered into a body lumen (also not shown) using thesheath body 154, as described elsewhere herein. In addition to theparticular configurations shown in FIGS. 7A and 7B, it is envisionedthat other embodiments may include different configurations of two ormore materials having differential properties to accomplish the same endresult.

Referring to FIGS. 8A and 8B, yet another embodiment of a peelable ortearable sheath body or tubular device 160 is shown. Generally, thesheath body 160 is constructed from an elongate panel, sheet, or othermember having an initially flat cross-section 161 with interlockingfeatures 162, 163 extending along opposite longitudinal edges. Thesheath body 160 may be formed by wrapping the flat member around amandrel or other structure or rolling the flat member until thelongitudinal edges 162, 163 are disposed adjacent one another, e.g., toform a substantially circular cross-section. The interlocking featureson the longitudinal edges 162, 163 may be engaged with one another tomaintain the sheath body 160 in its tubular shape. The mandrel, if used,may be removed, and the sheath body 160 incorporated into an apparatus,such as the apparatus 10 of FIGS. 1A-1C.

After using the sheath body 160 (or apparatus incorporating the sheathbody 160) to deliver a lead or other device, the sheath body 160 maythen be easily removed by applying enough force to pull apart the twointerlocking longitudinal edges 162, 163 while leaving behind the leador other device positioned within the body. This separation may befacilitated by providing tabs, elongated ends, handles, or other similarfeatures (not shown) on the proximal end of the sheath body 160 (e.g.,on the handle 13 shown in FIG. 1A) to facilitate initiation andpropagation of the peeling action (e.g., towards the distal end 14). Thesheath body 160 may be constructed using similar materials and methodsto those described elsewhere herein.

FIGS. 8A and 8B show interlocking edges that includes a generally “C”shaped pocket and a cylindrical tab that may be received within thepocket. Alternatively, FIG. 9A shows another embodiment in whichlongitudinal edge 163′ includes a flange, and longitudinal edge 162′includes a pocket for receiving the flange. In a further alternative,FIG. 9B shows another embodiment in which longitudinal edge 163″includes a tongue, and longitudinal edge 162″ includes a groove forreceiving the tongue. Thus, the longitudinal edges may be removablyengaged with one another. The longitudinal edges may be held togethersimply by friction and/or an interference fit. Alternatively, a weakadhesive or other material may be

It will be appreciated that elements or components shown with anyembodiment herein are exemplary for the specific embodiment and may beused on or in combination with other embodiments disclosed herein.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the scope ofthe appended claims.

1. An apparatus sized for introduction into a body lumen and comprisinga tubular device, the tubular device comprising: a main lumen extendingbetween a proximal end and a distal end of the tubular device; a sheathbody extending about the main lumen; and a circumferentially interruptedreinforcing layer attached to the sheath body and including first andsecond longitudinal edges, the first and second longitudinal edgesdefining a circumferential interruption, and each of the first andsecond longitudinal edges being defined by a loop; wherein thecircumferential interruption extends as a longitudinal channel betweenthe proximal and distal ends of tubular device; and the loop of thefirst longitudinal edge provides a first lumen of the tubular device,extending longitudinally alongside the main lumen thereof, and the loopof the second longitudinal edge provides a second lumen of the tubulardevice, also extending longitudinally alongside the main lumen thereof.2. The apparatus of claim 1, wherein the circumferentially interruptedreinforcing layer of the tubular device is attached within the sheathbody of the tubular device and maintained therein by at least one of:friction, bonding, and reflow incorporation therein.
 3. The apparatus ofclaim 1, wherein the circumferentially interrupted reinforcing layer ofthe tubular device comprises a tubular braid.
 4. The apparatus of claim1, wherein the longitudinal channel of the circumferential interruptionof the tubular device is filled with one or both of: a portion of thesheath body of the tubular device and an adhesive.
 5. The apparatus ofclaim 1, further comprising means to align a slitter with thecircumferential interruption of the tubular device.